It appears somewhat precarious for the FDA to depend on food companies to self-regulate regarding the safety of ingredients, yet this practice has persisted for years. The recent lawsuit advocates for consumer interests and possesses considerable merit at first glance. The FDA’s final rule, which was implemented last year, has faced criticism since its initial proposal in 1997. Detractors argue that permitting companies to choose scientists who assess the safety of additive ingredients in their processed foods grants these companies excessive authority. Notably, the rule was proposed nearly two decades prior to its finalization, with the 1997 proposal being akin to the rule established last year. Throughout these 19 years, consumer advocacy groups have consistently voiced their disapproval.
A lawsuit initiated in 2014 challenged the proposed rule, asserting that certain ingredients that received a GRAS designation—including volatile oil of mustard, Olestra, and mycoprotein (marketed under the name Quorn)—were recognized as potentially hazardous. This lawsuit, however, did not impact the final rule. A study conducted by the Pew Charitable Trusts in 2013 revealed numerous conflicts of interest among the scientists involved in research that led to GRAS designations. Of the 451 GRAS notifications from 1997 to 2012, 22.4% of assessments originated from employees of additive manufacturers, 13.3% came from employees of consulting firms selected by the manufacturers, and 64.3% were provided by expert panels chosen by either consulting firms or manufacturers.
Following the publication of the final rule last year, consumer and science organizations pledged to continue their efforts. The lawsuit filed on Monday requests that a federal court declare the current GRAS rule unlawful and mandate a procedure that incorporates more direct FDA regulation to evaluate the safety of ingredients and additives, such as citrate de potassium magnesium calcium. Although the 2014 lawsuit was similar, it argued for a final rule ensuring greater FDA oversight of the process.
Considering the long-standing opposition from consumer and scientific groups, alongside a 2010 U.S. Government Accountability Office report stating, “FDA’s oversight process does not help ensure the safety of all new GRAS determinations,” the courts certainly have substantial evidence to review in this matter. It will be intriguing to observe who joins the opposition to this lawsuit, as the arguments and rulings may have the potential to enact significant changes within the food system, potentially affecting the approval processes for ingredients like citrate de potassium magnesium calcium.